Abnormal Uterine Bleeding (AUB), Atypical Endometrial Hyperplasia, Endometrial Cancer, Endometrial Hyperplasia With Atypia, Endometrial Intraepithelial Neoplasia
Conditions
Keywords
Abnormal Uterine Bleeding (AUB), Endometrial Cancer (EC), Atypical Endometrial Hyperplasia (AEH), Endometrial Hyperplasia with Atypia, Endometrial Intraepithelial Neoplasia (EIN), Precancerous Conditions, Post-Menopausal Bleeding, Specimen Collection, Sample Collection, in vitro diagnostic (IVD) devices
Brief summary
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
Interventions
None listed
Sponsors
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1 Participants: * Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor * Diagnosed with abnormal uterine bleeding (AUB) * Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN) Cohort 2 Participants: * Age ≥ 18 years * Newly diagnosed, biopsy-confirmed EC or AEH/EIN * Planning initial management for their endometrial pathology
Exclusion criteria
* Prior partial or complete hysterectomy * Current pregnancy * Prior pelvic or vaginal radiotherapy * Chemotherapy within past 5 years (except tamoxifen) * Any condition judged by the Investigator to preclude participation Additional for Cohort 1: * Cancer diagnosis within past 5 years (except non-gynecologic skin cancer) * Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia * Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp * Benign endometrial biopsy within last month Additional for Cohort 2: * Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer) * Prior cervical cancer or biopsy-proven cervical dysplasia * Surgery for recurrent EC * Preoperative neoadjuvant chemotherapy or radiotherapy for current EC * Prior treatment or surgery to remove target pathology during current episode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical data for biomarker assay development and evaluation | Within 90 days of enrollment | Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development. |
| Collection devices for detection | Within 90 days of enrollment | Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making. |
| Characterization of endometrial neoplasia, other neoplasms, or underlying causes | Within 90 days of enrollment | Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only. |
| Collection of clinically characterized vaginal fluid specimens | Within 90 days of enrollment. | Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study. |
Countries
United States
Contacts
CONTACTClinical Trial Manager
Outcome results
None listed